Regulatory Guidance

Resources

For multi-site studies, the Sponsor or Sponsor's agent may submit all revised Investigator brochures, package inserts, and device manuals on behalf of the individual investigators at the time they are made available. E&I requires a summary of changes to be included with the submission.

For single-site studies, the Investigator is responsible for the submission of all revised Investigator brochures, package inserts, and device manuals at the time they are received from the Sponsor. E&I requires a summary of changes to be included with the submission.

The Investigator is responsible for the submission of all revised Investigator brochures, package inserts, and device manuals at the time they are received from the Sponsor. E&I requires a summary of changes to be included with the submission.